Medical line securement device

ABSTRACT

A securement device includes a simply-structured retention mechanism that permits a portion of a catheter hub or a similar medical article to be easily anchored to a patient, without the use of tape or needles and suturing. A unitary retainer desirably includes a base defining a locator mechanism. The locator mechanism interacts with a fitting of the medical device so as to position the medical device relative to the retainer. The locator mechanism also desirably guides the medical device fitting into contact with an adhesive member mounted on an outer surface of the retainer. In one form, the locator mechanism includes one or more posts that engage mating holes defined in the medical device fitting. In other forms, the locator mechanism includes a cradle defining an arcuate channel to receive a convex surface of the medical device, or a recess shaped to matingly receive the fitting. The retainer is attached to a flexible anchor pad that includes an adhesive bottom surface, which can be attached to the patient&#39;s skin. In use, a health care provider positions the medical device fitting on the retainer in a position established and guided by the locator mechanism, and attaches the fitting to the retainer via the adhesive member.

RELATED APPLICATION

[0001] This application is a divisional application of copendingapplication Ser. No. 08/970,223 filed on Nov. 14, 1997, issuing on May1, 2001 as U.S. Pat. No. 6,224,571.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to a securement device for securinga medical line or article to a patient.

[0004] 2. Description of Related Art

[0005] Medical treatment of patients commonly involves the use ofpercutaneously inserted catheters to direct fluids directly into thebloodstream, a specific organ or an internal location within thepatient, or to monitor vital functions of the patient. For instance,short, peripherally-inserted, intra-arteriovenous catheters are commonlyused to direct fluids and/or medications directly into the bloodstreamof the patient.

[0006] The fluid (e.g., parenteral liquid, medication, etc.) typicallydrains from a container positioned above the patient to feed undergravity or is delivered via an infusion pump. The fluid flows throughtubing and thence into the indwelling catheter. The catheter and thefluid tubing are commonly removably attached to each other by aconventional luer-lock connector.

[0007] In common practice, a health care provider uses adhesive, foam orsurgical tape to maintain the catheter in place on the skin of thepatient. The health care provider wraps a thin piece of tape around thehub of the catheter and then forms a “chevron” with the tape, placingthe ends next to the sides of the indwelling catheter. The health careprovider then places one piece of across and over the catheter hub,forms a loop in the tubing, places another piece of tape across thetubing loop, and places yet an additional piece of tape over thecatheter hub and the tubing section that has been looped around andextends next to the indwelling catheter. Subsequently, the health careprovider typically covers the insertion site and the indwelling catheterwith a transparent dressing.

[0008] The entire taping and dressing procedure takes several minutes ofthe health care provider's valuable time. In addition, thecatheterization process often requires relatively frequent disconnectionbetween the catheter and the fluid supply tube, as well as dressingchanges. For instance, intravenous catheterization is frequentlymaintained for several days, depending upon the condition of thepatient. The tubing is generally replaced every 48 to 72 hours in orderto maintain the sterility of the fluid and the free-flow of the fluidthrough the tubing. A health care provider thus must frequently changethe tubing and re-tape the connection. The health care provider alsomust frequently clean the insertion site about the indwelling catheterand change the dressings.

[0009] The health care provider thus uses a great deal of valuable timeapplying, removing and reapplying tape. The frequent application andremoval of the tape also commonly excoriates the patient's skin aboutthe insertion site.

[0010] In addition, the traditional method of intravenous cathetersecurement—surgical tape and transparent dressings alone—have not alwaysprevented catheter migration and/or dislodgment. Taped intravenouscatheters are also easily pulled out during a “routine” dressing change,especially by inexperienced health care providers. And if the cathetermigrates too far or dislodgment occurs, the health care provider mustreplace the catheter, thus exacerbating the time and expense required tomaintain the intravenous feed.

[0011] Prior securement methods also have not served the patient well.Surgical tape or foam strips are uncomfortable. Many patients also donot rest comfortably and worry about catheter dislodgment when theymove, when only tape and a dressing secure the catheter in place.

[0012] Several additional drawbacks result from the use of tape tostabilize the catheter. One is contamination. Health care providersoften tear off small strips of tape and place then on the hand rail onthe patient's bed. Clostridium and other bacteria, however, commonlyexist on these surfaces and can be transferred to the patient's skin inthe proximity of the insertion site.

[0013] In addition, tape securement requires the nurse to handle thetape while wearing protective latex gloves. Tearing adhesive tape tendsto produce microscopic and/or visible holes in the gloves and thusdestroys glove barrier protection.

[0014] A number of catheterization systems have been developed toimproved the stability of the catheter and to obviate the need forfrequent application and removal of surgical tape. Prior devices,however, have generally held the connector on the IV tubing securelyagainst the patient, rather than the catheter fitting itself.

SUMMARY OF THE INVENTION

[0015] The present invention involves the recognition that where (i) thecatheter securement device secures the connector on the tubing, ratherthan the catheter fitting, and (ii) the interconnection between the tubeconnector and the catheter fitting occurs across a bendable anatomicjoint (e.g., the patient's wrist), a possibility exists for relativemovement to occur between the indwelling catheter and the correspondingvessel (e.g., vein). As a result of such movement, the catheter undersome circumstances may become dislodged, requiring recatheterization ofthe IV catheter, re-securement of the catheter, and redressing of theinsertion site. Again, such catheter migration and/or dislodgment leadsto increased time and expense associated with maintaining an intravenousfeed.

[0016] A need therefore exists for a simply-structured securement devicethat retains a medical line in a fixed position on a patient's body, butreleases the medical line for dressing changes or other maintenance,even where the catheter-tubing connection spans an anatomic joint. Anadditional need exists for a securement device that incorporates aversatile medical line retaining mechanism, i.e. a device that can beused to attach one of a variety of medical line fittings to an insertionsite on a patient's body.

[0017] One aspect of the present invention involves a securement devicesystem for securing a medical line to a body of a patient. Thesecurement device comprises a mounting surface that is at leastpartially covered by an adhesive layer for attaching the securementdevice to the patient's body. A receiving surface is located distal ofthe mounting surface. An adhesive member at least partially covers thereceiving surface and is positioned to contact at least a portion of themedical line secured by the securement device. A locator mechanisminteracts with the medical line and positions the medical line portionon the receiving surface relative to the adhesive member.

[0018] A preferred method of manufacturing a medical line securementdevice involves affixing a sheet of a backing material to a sheet ofadhesive-backed foam material, then cutting a first pattern through thesheet of foam material without cutting through the sheet of backingmaterial, the first pattern at least partially defining an anchor pad. Asecond pattern is then cut through both the sheet of foam material andthe sheet of backing material, the second pattern defining on thebacking material a release layer for exposing the adhesive backing ofthe anchor pad prior to attaching the securement device to the patient'sbody. A retainer is formed (e.g., molded, or extracted) to include alocator mechanism that is adapted to interact with a portion of themedical line and to thereby guide the medical line into a positionrelative to the retainer. The retainer is attached to a surface of theanchor pad, and a patch of an adhesive material is applied to a surfaceof the retainer. A release layer is affixed over the adhesive patch, butis removable to expose the adhesive patch during use.

[0019] A preferred method of securing a medical line to a patientinvolves providing a securement device having a first adhesive member onone side, a second adhesive member on an opposite side, and a locatormechanism. The locator mechanism is engaged with a portion of themedical device so as to position the medical device portion generallyover the first adhesive member. The medical device thence is engagedwith the first adhesive member to secure the medical device to thesecurement device. The second adhesive member is placed on the patient'sbody to secure the securement device, and thus the retained portion ofthe medical line, to the patient.

[0020] Further aspects, features, and advantages of the presentinvention will become apparent from the detailed descriptions of thepreferred embodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The illustrated embodiments of the securement device are intendedto illustrate, and not to limit the invention, and contain the followingfigures:

[0022]FIG. 1 is a perspective view of a medical line securement deviceconfigured in accordance with a preferred embodiment of the presentinvention, and illustrates an exemplary catheter hub positioned abovethe securement device;

[0023]FIG. 2 is a top plan view of the securement device of FIG. 1;

[0024]FIG. 3 is a perspective view of a securement device configured inaccordance with another preferred embodiment of the present invention;

[0025]FIG. 4 is a perspective view of a securement device configured inaccordance with an additional preferred embodiment of the presentinvention;

[0026]FIG. 5 is a perspective view of a securement device configured inaccordance with another preferred embodiment of the present invention,and illustrates an exemplary catheter hub in a retained position;

[0027]FIG. 6 is a top plan view of the securement device of FIG. 5 in anopen position without the retained catheter hub;

[0028]FIG. 7 is a cross-sectional view of a portion of the securementdevice of FIG. 6 taken along line 7-7, and illustrates with thesecurement device in an open position with the catheter hub positionedabove the securement device;

[0029]FIG. 8 is a cross-sectional view of securement device of FIG. 5taken along line 8-8 and illustrates the securement device in a closedposition receiving the catheter hub;

[0030]FIG. 9 is a perspective view of a medical line securement deviceconfigured in accordance with an additional preferred embodiment of thepresent invention and illustrates a catheter fitting positioned abovethe securement device;

[0031]FIG. 10 is a cross-sectional view of the securement device of FIG.9, taken along the line 10-10;

[0032]FIG. 11 is a cross-sectional view of the securement deviceaccording to FIG. 10, but with tangs shown in an open position;

[0033]FIG. 12 is a cross-sectional view of the securement according toFIG. 10, but with a fitting of the medical line in the latched position;

[0034]FIG. 13 is a partially exploded perspective view of a securementdevice configured in accordance with another preferred embodiment of thepresent invention;

[0035]FIG. 14 is a perspective view of the securement device of FIG. 13in an assembled form and illustrates a catheter fitting positioned abovethe securement device;

[0036]FIG. 15 is a partially exploded perspective view of a securementdevice configured in accordance with an additional preferred embodimentof the present invention; and

[0037]FIG. 16 is a perspective view of the securement device of FIG. 15in an assembled form and illustrates a catheter fitting positioned abovethe securement device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

[0038] The present embodiments of the medical line securement device aredisclosed in the context of an exemplary intravenous (IV) catheter. Theprinciples of the present invention, however, are not limited to IVcatheters. Instead, it will be understood by one of skill in this art,in view of the present disclosure, that the securement devices andretainers disclosed herein also can be successfully utilized inconnection with other types of medical lines, including tubes for fluidcommunication and electrical wires. For example, but without limitation,the retainers disclosed herein can be adapted to retain CVCs, PICCs,Foley catheters, and hemodialysis catheters, surgical drainage tubes,feeding tubes, chest tubes, nasogastric tubes, scopes, as well as withelectrical wires or cables connected to external or implanted electronicdevices or sensors. One skilled in the art may also find additionalapplications for the devices and devices disclosed herein. Thus, theillustrations and descriptions of securement devices disclosed herein inconnection with a catheter are merely exemplary of one possibleapplication of the device.

[0039] Each of the embodiments described herein employ the same basicconcepts characteristic of the improved securement device, namelyattachment of a medical line or article to a patient by use of anadhesive member that adheres to the medical line or article. Thesecurement devices also all include interacting structure that operatesbetween the securement devices and a portion of the medical line orarticle (e.g., a fitting which either is releasably attached to themedical line or article or is integrally formed with the medical line orarticle). The interacting structure between the retainer and the portionof the medical line or article generally inhibits relative movementbetween the medical line and the securement devices in at least onedegree of freedom. This interaction also properly locates the portion ofthe medical line or article on the securement device and guides themedical line or article portion into contact with the adhesive member.

[0040] To assist in the description of the components of the securementdevices and retainers disclosed herein, the following coordinate termsare used. A longitudinal axis is generally parallel to a section of themedical line to be retained by the securement device, generally in theplane of a base or pad of the securement device (discussed below). Alateral axis is generally perpendicular to the longitudinal axis withinthe plane of the base. A transverse axis extends transverse to both thelongitudinal and lateral axes. FIG. 1 illustrates this coordinate systemto the side of the securement device. The illustrated coordinate systemapplies to the perspective views of each of the preferred embodimentsillustrated herein. In addition, as used herein, the “longitudinaldirection” refers to a direction substantially parallel to thelongitudinal axis. “The lateral direction” refers to a directionsubstantially parallel to the lateral axis. And, “the transversedirection” refer to a direction substantially parallel to the transverseaxis. These coordinates are used to describe structures and movement ofthe securement device of each embodiment. A detailed description of eachembodiment, and its associated method of use, now follows.

[0041] FIGS. 1-2 illustrate an securement device 8 constructed inaccordance with a preferred embodiment of the present invention. Thesecurement device 8 is configured to retain a catheter 10, eitherdirectly or by way of a fitting 12, as in the illustrated embodiment.Thus, the following description first provides a brief description ofthe catheter fitting 12 before describing the securement device 8 inorder to aid the reader's understanding of this embodiment.

[0042]FIG. 1 illustrates an exemplary short, peripheral IV catheter,such as the type available from B. Braun Mesungen AG. The fitting 12 ofthis catheter 10 includes a conical receptacle 14 in fluid communicationwith the catheter 10 and having a threaded rim 16 for releasablyattaching to a fluid tubing (not shown) to place the tubing in fluidcommunication with the catheter 10. The fitting 12 also includes a pairof lateral wings 18 that extend roughly perpendicularly from a lowerportion of the fitting 12. Each wing 18 includes a through-hole 20. Amedial surface 22 of the fitting 12, including portions of the lateralwings 18, has a generally flat, cruciform-shaped foot print.

[0043] The securement device 8 receives and directly anchors thecatheter fitting 12 to the patient, rather than holding a point in themedical line upstream of the catheter 10 (e.g., the connector betweenthe catheter and the fluid supply tube). For this purpose, thesecurement device 8 includes an adhesive member 24 against which themedial surface 22 of the catheter fitting 12 is placed. Desirably, theshape of the adhesive member 24 generally corresponds to the shape ofcatheter fitting's foot print, and the adhesive member 24 is coextensivewith or slightly smaller than the size of the fitting's foot print.Thus, in the illustrated embodiment, the adhesive member 24 hasgenerally a cruciform shape.

[0044] The adhesive member 24 desirably has a sufficient thickness andtackiness to either secure and/or encapsulate (at least to some degree)the catheter fitting 12 in order to inhibit relative movement betweenthe securement device 8 and the catheter fitting 12. The adhesive member24 can be applied to the securement device 8 in any of a variety ofconventional ways, such as by transfer technology (e.g., thin filmtransfer tape) or by sputtering. For instance, in the illustratedembodiment, the adhesive member 24 is formed of a transfer adhesiveavailable from Minnesota Mining and Manufacturing Company (3M), ofMinneapolis, Minn., as Part No. 950.

[0045] As seen in FIG. 1, a release layer 26 can initially cover theadhesive layer 24 before use. In the alternative, the packaging (notshown) for the securement device 8 can function as the release layer 24.In either case, a suitable material covers the adhesive member 24 priorto the securement device's application on a patient. Such suitablematerial includes, for example, but without limitation, a polycoated,siliconized paper.

[0046] The securement device 8 also includes a locator mechanism toproperly position the catheter fitting 12 on the adhesive member 24. Anyof a wide variety of locator mechanism can be used for this purpose, asillustrated by the various embodiments described below. For instance, asseen in FIGS. 1 and 2, the securement device 8 desirably includes atleast one post 28 which cooperates with one of the holes 20 in thecatheter fitting wings 20.

[0047] In the illustrated embodiment, the securement device 8 desirablyincludes a pair of posts 28; however, the securement device 8 can alsoinclude additional posts to suit a specific application. For example,where the securement device is designed to secure a relatively largefitting, the securement device can include four posts arranged at thecorners of a rectangle, for greater stability. As another example, threeposts can be used to firmly anchor a Y-site fitting.

[0048] The posts 28 can have any of a variety of lengths and diameters,as well have a variety of distances between them, depending upon theparticular application and the particular catheter fitting with whichthey are to interact. For applications with known catheters, each post28 desirably has a length of about 4 mm to 20 mm, and more particularlya length of about 6 mm; however, longer or shorter lengths also arepossible. The post diameter desirably is slightly smaller than thecorresponding hole 20 of the catheter fitting 12 but is sufficientlylarge to inhibit significant bending of the post 28 under normal forcesexperienced on the medical line. The posts 28 desirably are of comprisea polymer plastic material, with a diameter between 0.5 mm and 3 mm, andmore preferably with a diameter about 1.7 mm.

[0049] The posts 28 are laterally spaced at least wide enough toaccommodate the medical line or article to be anchored, and, in theillustrated embodiment, desirably correspond to the spacing between theholes 20 in the catheter fitting wings 18. For application with mostknown catheters, the posts 28 are spaced apart by a distance betweenabout 5 mm and about 40 mm, and more particularly by a distance equal toabout 15 mm.

[0050] In the illustrated embodiment, as seen in FIGS. 1 and 2, thesecurement device 8 includes a retainer, generally designated byreference numeral 30, mounted on a flexible anchor pad 32. The retainer30 includes a base 34 which supports the locator mechanism (e.g., theposts 28) and the adhesive member 24 of the retainer 30. The base 34desirably has a planar shape that defined in part a receiving surface(generally designed by reference numeral 36) for the catheter fitting12. The posts 28 extend generally normal to the receiving surface 36 ofthe base 34 with the adhesive member 24 located on the receiving surface36 and between the posts 28.

[0051] The base 34 and the posts 28 of the retainer 30 desirably areintegrally formed as a unitary piece. This can be accomplished in any ofa variety of ways well known to one of skill in the art. For instance,the entire retainer 30 can be injection molded, in order to reducefabrication costs. Suitable plastics from which the posts 28 and base 34can be made include, for example, but without limitation, polypropylene,polyethylene, and the like. In particular, acceptable materials includeTenite□ 811 low density polyethylene (LDPE) available commercially fromEastman Chemical Company, of Kingsport, Tenn., and polypropylene(#P6M5B-015) and polypropylene copolymer (#P6M5Z-036), both availablecommercially from Huntsman Chemical, Salt Lake City, Utah.

[0052] As mentioned above, the adhesive member 24 can be applied to thebase 34 in a variety of ways, including, but without limitation, bytransfer tape or sputtering. If applied by transfer tape, theapplication can be done as part of a converter process, described below.

[0053] The base 34 of the retainer 30 is attached to the anchor pad 32.The base 34 desirably is secured to the anchor pad 32 by a solvent bondadhesive, such as cyanoacrylate or other bonding material. One suchadhesive is available commercially as Part No. 4693 from 3M.

[0054] The anchor pad 32 comprises a flexible structural layer forsecuring the retainer 30 to a patient's skin. The pad 32 desirablycomprises a laminate structure with an upper foam layer (e.g.,closed-cell polyethylene foam), and a bottom adhesive layer. Theadhesive preferably is a medical-grade adhesive and can be eitherdiaphoretic or nondiaphoretic, depending upon the particularapplication. The anchor pad 32 desirably is formed from a polyethylenefoam tape ({fraction (1/32)} to ⅛ inch thick) with an acrylic adhesive,40 to 120 grams/square meter thick. Such foam with an adhesive layer isavailable commercially from New Dimensions in Medicine of Columbus,Ohio.

[0055] An upper surface of the foam layer of the anchor pad 32 isroughened by corona-treating the foam with a low electric charge. Theroughened or porous upper surface of the anchor pad 32 improves thequality of the adhesive joint formed by the cyanoacrylate (or by anothertype of adhesive or bonding material) between the base 34 and the anchorpad 32. In the alternative, the flexible anchor pad 32 can comprise amedical-grade adhesive bottom layer, an inner foam layer and an upperpaper or other woven or non-woven cloth layer.

[0056] A removable paper or plastic backing or liner 38 desirably coversthe bottom adhesive surface before use. This release layer 38 preferablyresists tearing and is divided into a plurality of pieces to easeattachment of the pad to a patient's skin. In the illustratedembodiment, the backing is a polycoated, siliconized paper.

[0057] The backing desirably is split along a center line CL of theflexible anchor pad 32 in order to expose only half of the adhesivebottom surface at one time. The backing 38 also advantageously extendsbeyond at least one edge of the anchor pad 32, as illustrated, tofacilitate removal of the backing 38 from the adhesive layer.

[0058] Although not illustrated, the retainer 30 and/or the anchor pad32 can include suture holes in addition to the adhesive layer to furthersecure the anchor pad to the patient's skin.

[0059] In the illustrated embodiment, the anchor pad 32 also desirablyincludes a pair of opposing concave sections that narrows the center ofthe anchor pad 32 proximate to the retainer base 34. As a result, theperipheral ends of the anchor pad 32 have more contact area to providegreater stability and adhesion to a patient's skin, while allowing theretainer 30, which is located at center section of the anchor pad 32, tobe placed adjacent to a catheter insertion site.

[0060] The anchor pad 32 and release layer 38 (i.e., backing) are formedusing a converter process. A sheet of backing material is initiallyapplied onto the adhesive surface of the foam material. (The foam ispurchased with a backing; however, a new backing desirably is appliedwhich includes printed indicia that identifies the manufacturer of thesecurement device 8.)

[0061] A first pattern is cut multiple times in the sheet ofadhesive-backed foam material through the conversion process. This maybe done using a die-cut technique which “kisscuts” only the foammaterial in the first patters without cutting the backing material. Thecut first pattern desirably corresponds to at least a portion of theanchor pad 32. That is, the first pattern, which is cut into the foammaterial, at least partially defines the shape of the anchor pad 32.

[0062] A second pattern is then cut multiple times into the sheet ofadhesive-backed material (i.e., the foam material) and the backingmaterial. The second pattern defines the balance of the anchor padshape, as well as the exposed portion of the release layer 38. Thisprocess likewise can be done by die-cutting.

[0063] The release liner 38 also is cut into its two halves withoutcutting the foam layer. This process can be done either before or afterthe second pattern is cut and also can be accomplished by a die cut.Multiple anchor pads thus are produced from a single sheet thefoam/adhesive/backing laminate structure through this conversionprocess.

[0064] In use, the health care provider removes the securement devicefrom its protective, sterile packaging (not shown) and peals off therelease layer 26 from the adhesive member 24 if provided separate fromthe packaging. Otherwise, the adhesive member 24 emerges uncovered fromthe packaging. The health care provider then aligns the posts 28 withsuture holes 20 in the catheter fitting wings 18 and inserts the posts28 into the holes 20. The interaction between the holes 20 and the posts28 properly positions the catheter fitting 12 on the retainer 30. Thehealth care provider then moves the catheter fitting 12 into contactwith the adhesive member 24 and presses the catheter fitting 12 againstthe retainer 30 to ensure good contact between the adhesive member 24and the medial surface 22 of the catheter fitting 12. As a result of thecorresponding shapes of the adhesive member 24 and medial surface 22 ofthe catheter fitting 12, the medial surface 22 completely covers theadhesive member 24, thereby inhibiting exposure of the adhesive member24. Because exposed adhesive can become sites for bacterial growth,minimizing such exposure substantially reduces the risk of a insertionsite infection.

[0065] The health care provider desirably secures the anchor pad 32 tothe patient after attaching the catheter fitting 12 to the retainer 30.This step can be done before catheter fitting attachment, but itrequires placing the anchor pad 32 on the patient in a positionprecisely aligning the retainer 30 beneath the catheter fitting 12.Regardless of the order of these acts, the health care provider securesthe anchor pad to the patient by first removing one half of the releaselayer and pressing the anchor pad against the patient's skin, adhesiveside face down. The health care provider then removes the other half ofthe release layer and smoothes the anchor pad 32 against the patient.The securement device 8 in this position securely anchors the catheterfitting 12 to the patient.

[0066]FIG. 3 illustrates a medical line securement device 8 a inaccordance with another embodiment of the present invention. The abovedescription in relation to FIGS. 1 and 2 applies equally to theembodiment of FIG. 3, unless otherwise indicated. In addition, likereference numerals are used to indicate like features among theembodiments, with the letter “a” added as a suffix to refer to featuresof the present embodiment.

[0067] The securement device 8a comprises a retainer 30 a. The retainer30 a is similar to the retainer illustrated in FIGS. 1-2, except thatthe base 34 a of the retainer 30 a comprises a raised pedestal 40extending upwardly from the base 34 a and defining a portion of thereceiving surface 36 a. The raised pedestal 40, the base 34 a and theposts 28 a desirably are all integrally formed in an unitary retainer 30a.

[0068] The adhesive member 24 a is formed on an upper surface of theraised pedestal 40, and a release layer 26 a covers the adhesive member24 a. Alternatively, the packaging (not shown) functions as the releaselayer, as described above.

[0069] The raised pedestal 40 of the retainer 30 a preferably has aplanar upper surface on which the adhesive layer 24 a is located.Desirably, the plane generally defined by the upper surface of theraised pedestal 40 desirably forms an acute angle with the planarsurface of the base 34 a. The angled upper surface imparts an angularorientation to the catheter fitting relative to the patient's skin. Theresulting incident angle desirably ranges between about 0═ and 15═,depending upon the application of the catheter securement device 8, asknown in the art.

[0070] An anchor pad 32 a supports the retainer 30 a. A release layer(not shown) covers an adhesive underside of the anchor pad 32 a prior toapplication of the anchor pad 32 a to the patient, as described above.

[0071]FIG. 4 illustrates a medical line securement device 8 b inaccordance with another embodiment of the present invention. The abovedescription with respect to the embodiment of FIGS. 1 and 2 appliesequally to the embodiment of FIG. 4, unless otherwise indicated. Inaddition, like reference numerals are used to indicate like featuresamong the embodiments, with the letter “b” added as a suffix to refer tofeatures of the present embodiment of FIG. 4.

[0072] The retainer 30 b is similar to the retainer of FIG. 1, exceptthat the retainer 30 b includes a cradle 42 extending upwardly from thebase 34 b of the retainer 30 b. The adhesive member 24 b desirably lieswithin the cradle 42 and covers at least a portion of the receivingsurface 38 b defined by the cradle 42. A release layer 26 b caninitially cover the adhesive member 24 b, or the packaging can servethis function, as described above.

[0073] In addition, a foam layer 46 desirably is interposed between thesurface of the channel 44 and the adhesive layer 24 b. The foam layer 46provides for good contact between the adhesive layer 24 b and thesurface of the catheter fitting, despite the presence of protuberanceson the surface of the catheter fitting. That is, the foam layer 46allows the adhesive layer 24 b to follow the contours of the juxtaposedcatheter fitting surface.

[0074] The cradle 42 preferably has a concave, arcuate upper surfacethat forms a channel 44 and functions as the receiving surface of theretainer 30 b. Desirably, the surface of the channel 44 conformssubstantially to a portion of a surface of a cone, thereby allowing thechannel to mate easily with a conically-shaped catheter fitting, such asthe fitting illustrated in FIG. 1. Because the arcuate surface of thechannel 44 can be used to guide a catheter fitting into a desiredposition relative to the retainer 30 b and onto the adhesive layer 24 b,posts 28 b (shown in phantom lines in FIG. 4) are optional in thepresent embodiment. Such posts 28 b, in conjunction with correspondingsuture holes, such as the holes 20 in the catheter fitting wings (seeFIG. 1), may make it easier for a health care provider to position acatheter fitting relative to the retainer 10 c and therefore may be usedif desired. In this embodiment, both the shape of the channel 44 and theposts 28 b, if included, function as the locator mechanism of theretainer 30 b.

[0075] An anchor pad 32 b supports the retainer 30 b. A release layer(not shown) desirably covers an adhesive underside of the anchor pad 32b prior to application of the anchor pad 32 b to the patient, asdescribed above.

[0076] FIGS. 5-8 illustrate a medical line securement device 8 c inaccordance with another embodiment of the present invention. The abovedescription with respect to the embodiment of FIGS. 1 and 2 appliesequally to the embodiment of FIGS. 5-8, unless otherwise indicated. Likereference numerals are used to indicate like features among theembodiments, with the suffix “c” added to refer to features of thepresent embodiment.

[0077] The retainer 30 c and anchor pad 32 c of securement device 8 care similar to those illustrated in FIG. 1, except that the locatormechanism takes the form of a cradle 48 with movable walls 50. Theadhesive member 24 c desirably lies within the cradle 48 and covers atleast a portion of the receiving surface as defined by the cradle 48. Arelease layer (not shown) can initially cover the adhesive member 24 cor the packaging can serve this function, as described above.

[0078] As best understood from FIGS. 6, 7 and 8, the cradle includes achannel 52 of tapering width, which includes an arcuate surface thatfunctions as the receiving surface of the retainer 30 c. Desirably, theshape of the channel 52 conforms substantially to a portion of a cone(i.e., has a frusto-conical shape), thereby allowing the channel 52 tomate easily with a conically-shaped section of the catheter fitting 12c.

[0079] The channel 52 is defined in part by the opposing wall sections50. Each wall section 50 has an arcuate shape of a radius of curvaturethat generally matches the catheter fitting 12 c. Each wall section 50also extends through an arc length of generally greater than 90□ suchthat together the wall sections 50 surround at least 180□ of theconical-shaped catheter fitting 12 c.

[0080] A flexible coupling, generally identified by reference numeral54, interconnects the wall sections 50 of the cradle 48 and supports thecradle 48 about retainer base 34 c. In the illustrated embodiment, theflexible coupling 54 is integrally formed with the base 34 c, as well aswith the wall sections 50. The flexible coupling 54 includes a pair ofgenerally parallel rails 56. Each rail 56 includes a necked-down sectionformed between the base 34 c and the corresponding wall section 50. Thisneck section is flexible and permits the corresponding wall section 50to move relative to the base 34 c.

[0081] The wall sections 50 thus are movable relative to each other andto the base 34 c. Desirably, the flexible coupling 54 normally holds thewall sections 50 in an open position, as illustrated in FIG. 7, in whichthe upper ends (distal of the base 34 c) of the wall sections 50 arespaced apart. The flexible coupling 54 permits the wall sections 50 tomove toward each other into a closed position, as seen in FIG. 8. Inthis position, the upper ends of the wall sections 50 are spaced closelytogether, and the channel's shape and size generally matches that of theretained section of the catheter fitting 12 c. The cradle 48 in theclosed position thus extends more than 180□ around the circumference ofthe catheter fitting 12 c.

[0082] The flexible coupling 54 also includes an actuator mechanism tomove the wall sections into the closed position once the channel 52 hasreceived the catheter fitting 12 c. In the illustrated embodiment, theactuator mechanism includes a pair of lugs 58 that extend from the lowerends of the wall sections 50 between the rails 56. Each lug 58 has aninner surface (i.e., a surface within the channel 52) with an arcuateshape that generally matches that of the corresponding wall section 50.The lugs 50 are also oriented and sized to have a slight upwardlyorientation when the cradle 48 is in the open position,, as seen in FIG.7. But when the catheter fitting 12 c is pressed into the channel 52,the lugs 58 move downward. The downward movement of the lugs 58 causesthe attached wall section 50 to pivot about the corresponding rail 56with the neck section of the rail 56 flexing, as seen in FIG. 8.

[0083] A foam layer 60 is placed within the channel 52 and lines atleast a portion of the channel's surface. The foam layer 60 not onlycompensates for irregularities in the catheter fittings surface, but italso acts as a substrate for the adhesive member 24 c. In theillustrated embodiment, the foam layer 60 and the adhesive layer 24 cline the entire inner surface of the cradle's channel 52.

[0084] In use, the conical section of the catheter fitting 12 c isinserted into the cradle 48 while the flexible coupling 54 holds thecradle walls 50 in the open position. The opposing walls 50 of thecradle 48 then close about the fitting 12 c, placing the adhesive member24 c in contact with the outer surface of the fitting 12 c therebysecuring the fitting 12 c to the retainer 30 c.

[0085] FIGS. 9-12 illustrate a medical line securement device 8 d inaccordance with another embodiment of the present invention. The abovedescription with respect to the embodiment of FIGS. 1 and 2 appliesequally to the embodiment of FIGS. 9-12, unless otherwise indicated likereference numerals are used to indicate like features among theembodiments, with the letter “d” added to refer to features of thepresent embodiment.

[0086] The retainer 30 d comprises a clamping mechanism formed by a pairof opposing latches 62. The latches 62 are spaced apart from each otheron the base 34 d, and the adhesive member 24 d is located between thelatches 62. In the illustrated embodiment, the latches 62 and base 34 dare integrally formed together in the form of a unitary retainer 30 d,such as, for example, but without limitation, by molding, extracting, orthermal forming, and the adhesive member 24 is applied in any of theabove-described manners.

[0087] Each latch 62 includes a tang 64, which projects toward the otherlatch 62, and a generally upright support 66, which suspends the tang 64above the base 34 d. An actuator or lug 68 is attached to the support 66at a point above the base 34 d. The actuator 68 desirably includes aroughened upper surface and/or friction ridges in order to enhancefrictional contact between the actuator 68 and the user's finger tips.In the illustrated embodiment, each actuator 68 lies to the outerlateral side of the corresponding tang 64 at the top of the uprightsupport 66. In this position, movement of the actuator 68 toward thebase 34 d causes the support 66 to flex and moves the tang 64 away fromthe other latch 66, as seen in FIG. 11.

[0088] In the illustrated embodiment, the upright supports 66 haveelongated shapes and are arranged on the base 34 d generally parallel toeach other. The supports 66, together with the base 34 d, define agenerally rectangular channel 70. The opposing tangs 64 of the latches62 reduce the size of the channel's upper opening. The floor of thechannel 70 defines at least a portion of the receiving surface 36 d ofthe retainer 30 d.

[0089] The channel 70 is sized to receive the catheter fitting wings 18d, and the latches 62 are arranged on the base 34 d to snap over thewings 34 d to latch the catheter fitting 12 d within the channel 70.

[0090] In operation, both actuators 68 are depressed by finger pressure,as schematically illustrated in FIG. 11, causing the supports 66 to bendlaterally outward. This outward bending of the supports 66 allowslateral wings 18 d of the catheter fitting to be placed between thesupports 66, thereby bringing a medial surface 22 d of the fitting 12 din contact with the adhesive pad 24 d. After insertion of the catheterfitting wings 18 d into the channel 70, the finger pressure on theactuators 68 can be released, thereby allowing the tangs 64 to partiallycover an upper surface of the catheter fitting wings 18. Accordingly,the fitting 12 d is secured to the retainer 30 d in two ways: first, bythe adhesive force of the adhesive member 24 d to the medial surface 22d of the fitting 12 d; and second, by the placement of tangs 64 over topof the fitting wings 18 d.

[0091] FIGS. 13-14 illustrate a medical line securement device 8 e inaccordance with another embodiment of the present invention. The abovedescription with respect to the embodiment illustrated in FIGS. 1 and 2applies equally to the embodiment of FIGS. 13-14, unless otherwiseindicated. Like reference numerals are used to indicate like featuresamong the embodiments, with the suffix “e” added to refer to features ofthe present embodiment.

[0092] The retainer 30 e comprises plate with a recess or well formedtherein. The plate can be formed of any of a wide variety of materials,including a plastic polymer. In the illustrated embodiment, however, theretainer 30 e comprises a foam pad defining an aperture 72 therethrough.As shown in FIG. 14, the aperture 72 has a shape corresponding to theshape of a catheter fitting's foot print, and thereby locates thecatheter fitting 12 e relative to the retainer 30 e.

[0093] An adhesive member 24 e is applied to an anchor pad 32 egenerally at the center of the pad 32 e. The size and shape of theadhesive member 24 e desirably matches the size and shape of the foampad 30 e. The adhesive member 24 e desirably has a uniform thickness andcovers the entire area within its perimeter. As a result, a portion ofthe adhesive member 24 e is exposed through the opening. A release layer(not shown) or the product packaging desirably covers the adhesive ember24 e prior to use, as described above.

[0094] The foam pad retainer 30 e and its aperture 72 can be formedduring a conversion process during a die cut procedure. The applicationof the adhesive member 24 e and the attachment of the foam pad retainer30 e to the adhesive member 24 e can also occur as steps during theconversion process.

[0095] Although not illustrated, the well or recess need not extendentirely through the foam pad, but rather can take the form of anembossment. In this form, the adhesive member can be applied to thefloor of the recess so as to be accessible from a side of the anchor padopposite of the patient's skin. Again, at least a portion of the recessis configured to correspond to the secured portion of the catheterfitting wings in shape and size.

[0096] In operation, the catheter fitting 12 e is moved toward andplaced into the recess 72 so as to position a medial surface 22 e of thefitting 12 e relative to the adhesive member 24 e. The medial surface 22e is thence pressed into contact with the adhesive member 24 e to securethe catheter fitting 12 e to the securement device 8 e. The anchor pad32 e is secured to the patient's skin in the manner described above.

[0097] FIGS. 15-16 illustrate a medical line securement device 8 f inaccordance with another embodiment of the present invention. Thedescription of the embodiment of FIGS. 1 and 2 applies equally to theembodiment of FIGS. 15-16, unless otherwise indicated. Like referencenumerals are used to indicate like features among the embodiments, withthe suffix “f” added to refer to features of the present embodiment.

[0098] This embodiment is also similar to that illustrated in FIGS.13-14, except that the need for a retainer. The retainer illustrated inFIG. 13 is eliminated in the present embodiment, and a recess or well 74is defined in the anchor pad 32 f itself. In the illustrated embodiment,the recess 74 extends entirely through the anchor pad 32 f; however, therecess can take the form of an indentation in the pad 32 f. In eithercase, the recess 74 desirably has a similar shape and size to at least aportion of the catheter fitting 12 f. And preferably, the recess 74generally matches the foot print of the catheter fitting 12 f in shapeand size.

[0099] The adhesive member 24 f is located on the bottom of the recess.In the illustrated embodiment, though, where the recess extends throughthe pad 32 f, a substrate 76 supports the adhesive member 24 f at thislocation. The adhesive member 76 desirably covers the entire substrate76 and secures it to a side of the anchor pad on which the adhesivelayer is formed. Thus, the substrate can include adhesive layers on bothof its sides.

[0100] The use of the present securement device 8 f is similar to thatassociated with the securement device illustrated in FIGS. 13 and 14.The catheter fitting 12 f is moved toward and placed into the recess 74so as to position a medial surface 22 f of the fitting 12 f relative tothe adhesive member 24 f. The medial surface 22 f is thence pressed intocontact with the adhesive member 24 f to secure the catheter fitting 12f to the securement device 8 f. The anchor pad 32 f is secured to thepatient's skin in the manner described above.

[0101] As common to all of the embodiments described above, thesecurement device includes adhesive layers on two sides. One sideadheres to the patient, while the other side adheres to the medical lineor article. In order to properly position the medical line on thesecurement device and to enhance the speed and ease of applying thesecurement device, each of the above-described securement devices alsoinclude a locator mechanism. Proper positioning promotes good contactbetween the adhesive member and the medical line or article to enhancesecurement, as well as ensures that the medical line or articlecompletely covers the adhesive member. As a result, the adhesive tendsnot to become a sites for bacterial growth. The locator mechanism alsoallows the health care provider to properly position the medical line orarticle on the securement device with minimum time and effort.

[0102] For use with catheter type devices, each of the securementdevices described above secures the catheter fitting to the patient,rather than secures the connector on the tubing to the patient as doneby prior devices. The catheter thus does not move with movement of ananatomic joint when an interconnection between the catheter and thetubing spans across the joint.

[0103] Also as common to each of the above-described embodiments, thesecurement device provides a sterile, stable, efficient way to anchor amedical line or article to a patient. The securement device is quicklyand easily applied to the medical line or article by using the locatormechanism, and is equally quickly and easily applied to the patient'sskin. During the application process, the health care provider need notcontact the adhesive layers with his or her gloves. Use of thesecurement device thus does not degrade glove protective. Once secured,the securement device stabilizes the catheter and substantially preventscatheter movement and migration.

[0104] Although not illustrated, each of the above-described securementdevices can include one or more tube clips, especially for use withintravenous catheters. An exemplary tube clip is described andillustrated in U.S. Pat. No. 5,578,013, issued in the name of Steven F.Bierman, on Nov. 26, 1996, and to the assignee hereof, which is herebyincorporated by reference. The tube clip can have a plate-like baseadhered to the anchor pad and be located on either side of the retainerto accommodate left or right hand mounting.

[0105] The tube clip desirably defines a channel having a generallycircular cross-sectional configuration truncated to form an upperorifice. The diameter of the channel is desirably slightly less thanthat of the fluid supply tube so as to ensure a secure interconnection.The channel receives a portion of the fluid supply tube through theorifice upon application of gentle pressure or by pulling the tubingacross and through the orifice of the tube clip. The clip surrounds asubstantial portion of the tubing with the tubing positioned within thechannel.

[0106] In use, a health care provider loops the IV supply tubing aroundfrom the insertion site and insert a portion of the tubing into the tubeclip. The looped section has sufficient slack to form a conventionalsafety loop. The safety loop absorbs any tension applied to the fluidsupply tube to inhibit pulling of the catheter.

[0107] The skilled artisan will also recognize the interchangeability ofvarious features from different embodiments. For instance, the angularorientation of the receiving surface illustrated in FIG. 3 can beemployed with the cradles illustrated in FIGS. 4 and 5. Thus, variousfeatures of the embodiments can be combined in order to adapt thesecurement device to a particular application.

[0108] Although this invention has been described in terms of certainpreferred embodiments, other embodiments apparent to those of ordinaryskill in the art are also within the scope of this invention.Accordingly, the scope of the invention is intended to be defined onlyby the claims that follow.

What is claimed is:
 1. A method of manufacturing a securement device forretaining a medical line to the body of a patient comprising: affixing asheet of a backing material to a sheet of adhesive-backed foam material;cutting a first pattern through the sheet of foam material withoutcutting through the sheet of backing material, the pattern at leastpartially defining an anchor pad; cutting a second pattern through boththe sheet of foam material and the sheet of backing material, the secondpattern defining a release layer for exposing the adhesive backing ofthe anchor pad prior to attaching the securement device to the patient'sbody; forming a retainer that defines a locator mechanism adapted tointeract with a portion of the medical line and thereby guide themedical line into a position relative to the retainer; attaching theretainer to the upper surface of the anchor pad; and applying a patch ofan adhesive material to an upper surface of the retainer.
 2. A method ofmanufacturing a securement device as in claim 1, wherein the adhesivepatch is applied by spray-sputtering an adhesive onto the upper surfaceof the retainer.
 3. A method of manufacturing a securement device as inclaim 1, wherein the adhesive patch is applied by transferring theadhesive patch to the retainer using transfer tape.
 4. A method ofmanufacturing a securement device as in claim 1 additionally involvingof corona-treating the upper surface of the anchor pad with a lowelectric charge before attaching the retainer to the anchor pad.
 5. Amethod of manufacturing a securement device as in claim 1 whereinattaching the retainer to the anchor pad involves adhering the retaineronto a surface of the pad using a solvent bond adhesive.
 6. A method ofmanufacturing a securement device for retaining a medical line to thebody of a patient comprising: cutting a foam sheet into a first shape;cutting an aperture through the foam sheet, the aperture beingpositioned on the first shape; attaching a substrate to the foam pad;and applying a layer of adhesive so as place the adhesive layer suchthat at least a portion of the adhesive layer is accessible through theaperture.
 7. A method of manufacturing a securement device as in claim6, wherein the layer of adhesive is applied by spray-sputtering anadhesive onto the substrate.
 8. A method of manufacturing a securementdevice as in claim 6, wherein the layer of adhesive is applied bytransferring the adhesive to the substrate using transfer tape.
 9. Amethod of manufacturing a securement device as in claim 6 additionallycomprising corona-treating the upper surface of the foam pad with a lowelectric charge.
 10. A method of manufacturing a securement device as inclaim 6, wherein the substrate is attached to the foam pad using asolvent bond adhesive.
 11. A method of manufacturing a securement deviceas in claim 6, wherein the substrate comprises a double sided adhesivetape.
 12. A method of manufacturing a securement device as in claim 6,wherein the substrate comprises an anchor pad used to attach thesecurement device to the skin of a patient.